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Characterization of High Density Lipoprotein (HDL) in Type 2 Diabetes (T2D) After Fenofibrate or Niacin Treatment (LOWHDL)

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ClinicalTrials.gov Identifier: NCT02153879
Recruitment Status : Completed
First Posted : June 3, 2014
Last Update Posted : June 3, 2014
Sponsor:
Collaborator:
Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders
Information provided by (Responsible Party):
LUIS MASANA, MD, Institut Investigacio Sanitaria Pere Virgili

Tracking Information
First Submitted Date  ICMJE May 26, 2014
First Posted Date  ICMJE June 3, 2014
Last Update Posted Date June 3, 2014
Study Start Date  ICMJE February 2009
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2014)
HDL particles size and number assessed by nuclear magnetic resonance (NMR) and reported as nm and micromol/L [ Time Frame: Two periods of 12 weeks treatment according to crossing over design ]
HDL particles were studied by NMR in T2D patients after treatment with fenofibrate or Niacin
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2014)
Apolipoprotein A1 (Apo A1), apolipoprotein A2 (Apo A2), paraoxonase (PON) HDL concentration (g/l - mg/l) [ Time Frame: Two periods of 12 weeks treatment according to crossing over design ]
Apoprotein and antioxidant enzymes composition of HDL were also measured
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 2, 2014)
Lecithin-cholesterol acyltransferase (LCAT) and cholesteryl ester transfer protein (CETP) activity (AU - pmol/h*μl) and mass (microg/ml) [ Time Frame: Two periods of 12 weeks treatment according to crossing over design ]
LCAT and CETP mass and activities were measured;
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Characterization of High Density Lipoprotein (HDL) in Type 2 Diabetes (T2D) After Fenofibrate or Niacin Treatment
Official Title  ICMJE Qualitative and Quantitative Characterization of HDL in T2D After Fenofibrate or Niacin Treatment in Spanish Population
Brief Summary

The structural and functional alterations of high density lipoproteins (HDL) levels in type 2 diabetes (T2D) patients linked to hypertriglyceridemia, hyperglycemia, insulin resistance, inflammation and oxidation, play a major role in the increased macrovascular risk in these patients. An impaired function of the adipose tissue (AT) in T2D contributes to low HDL concentrations.

Objectives: 1) Quantitative and qualitative characterisation of HDL subclasses by ultracentrifugation, proteomic and metabolomic techniques. 2) To study the relationship between the HDL subclasses, preβ1 HDL and remnant HDL, and clinical determinants of arteriosclerosis. 3) Functional in vitro studies of the HDL subclasses determined in Objective 1. 4) To study the role of AT determining the low HDL levels. 5) To study the impact of HDL increasing drugs on HDL qualitative changes.

Detailed Description Groups of subjects: a) Diabetic patients with low HDL; b) Non-diabetic patients with low HDL; c) Diabetic patients with normal HDL levels; and d) Non-diabetic patients with normal HDL levels. The studies will be performed after washing out lipid lowering drugs. Intima media thickness (IMT) will be performed in all groups. Main biochemical techniques will be centralised. Isolation and characterisation of HDL subclasses and remnant HDL, as well as a determination and preβ1 HDL will be performed. HDL studies examining HDL proteomic and metabolomic profiles will be performed. Functional studies will determine the effects on the endothelium, inflammation, cholesterol efflux and oxidation according the qualitative changes. These HDL measurements will be repeated in group (a), after they are treated with fibrates or Niacin. HDL metabolism in adipocytes will be extensively studied, and the clinical associations between HDL alterations and plasma AT-derived molecules will be examined.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Type 2 Diabetes Mellitus
  • Dyslipidemia
Intervention  ICMJE
  • Drug: Fenofibrate
    fenofibrate 145/day for 12 weeks
    Other Name: Secalip
  • Drug: Niacin plus laropiprant
    Niacin 2 g/day plus Laropiprant for 12 weeks
    Other Name: Tredaptive
Study Arms  ICMJE
  • Experimental: Fenofibrate
    Fenofibrate 145 mg/day for 12 weeks
    Intervention: Drug: Fenofibrate
  • Experimental: Niacin plus Laropiprant
    Niacin 2g/day plus Laropiprant for 12 weeks
    Intervention: Drug: Niacin plus laropiprant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 2, 2014)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Type 2 diabetic patients
  • Age from 30 years to 70 years
  • HDL not exceeding 50 mg/dl in men or 60 mg/dl in women

Exclusion Criteria:

  • to be a smoker
  • To be diagnosed with diabetes less than three months before
  • To have triglyceride levels above 400 mg/dl
  • Glycated hemoglobin higher than 9%
  • Albuminuria above 300 mg/mg creatinine
  • Chronic kidney disease (eFGR <30 ml/min/1.73 m2)
  • Advanced retinopathy
  • Neuropathy
  • Cardiovascular disease in the last three months
  • Chronic liver insufficiency
  • Neoplastic disease or any chronic or incapacitating disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02153879
Other Study ID Numbers  ICMJE IISPV-HUSJR-LOWHDL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party LUIS MASANA, MD, Institut Investigacio Sanitaria Pere Virgili
Study Sponsor  ICMJE Institut Investigacio Sanitaria Pere Virgili
Collaborators  ICMJE Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders
Investigators  ICMJE
Study Director: Luis Masana, Professor Institut Investigacio Sanitaria Pere Virgili
PRS Account Institut Investigacio Sanitaria Pere Virgili
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP